About this trial
This pilot study seeks to understand how changes in the bacteria composition (microbiome) of the gut may be associated with the occurrence of fatigue and chemotherapy-induced nausea (CIN) in women undergoing chemotherapy for early stage breast cancer. Patients undergoing chemotherapy may experience fatigue or nausea as a result of their treatment. Known risk factors for fatigue and CIN do not explain the differences in fatigue and CIN occurrence between patients, but changes in the functions of the gut microbiome may be related to the occurrence of fatigue and CIN. This study collects stool samples from breast cancer patients before and after chemotherapy to evaluate how changes in the microbiome may be associated with fatigue and CIN.
Eligibility criteria
Qualifiers
Subjects with a diagnosis of early stage breast cancer planning to receive moderate to highly emetogenic chemotherapy will be recruited at Mayo Clinic Health Systems including Mankato and Albert Lea; Mayo Clinic Arizona; Mayo Clinic Rochester (Minnesota); and Mayo Clinic Florida
At least 20 years of age
Last chemotherapy more than 3 years ago
Scheduled to receive moderate to highly emetogenic chemotherapy with or without targeted therapies including immunotherapies
Disqualifiers
Metastatic disease
Concurrent radiation therapy
Concurrent antibiotic treatment
Trial design
Treatments tested in this trial
- Biospecimen Collection
- Questionnaire Administration
Treatment groups
Locations
5Sponsors and collaborators
Mayo Clinic
Lead sponsor